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Preparation of Media and Buffers for Cell Cultivation in the Biopharmaceutical Industry

Cells need optimal ambient conditions so that they can successfully propagate. In addition to the agitation speed of a bioreactor and temperature, the dissolved oxygen saturation and pH of the medium are decisive for cell growth. Media and buffers in single-use bags equipped with a magnetic impeller assembly are stirred in large mixing tanks. Then these media are pumped through sterile tubing into the bioreactor.

Products: LevMixer® control unit, Flexel® Palletank® for LevMixer®, single-use Flexel® bag for LevMixer®, IF platform, Combics terminal, printer

Integrated Single-use Solutions for the Manufacture of Biopharmaceuticals

Safety, flexibility and efficiency are playing an ever-increasing role in the manufacture of biopharmaceuticals. For this reason, demand is steadily rising for sterile single-use products and systems that connect these products easily, flexibly and safely. Configurable and scalable system solutions, such as FlexAct®, can be used in all process steps – in preparation of media and buffers, cell harvesting, crossflow filtration, viral clearance, virus inactivation, polishing and in the form - fill und form - transfer process steps.

Products: FlexAct® Central Operating Module (COM)

Cell Cultivation in Biopharmaceutical Processes

To enable cells to grow optimally in the production of active pharmaceutical ingredients, cells are cultivated in a bioreactor under controlled conditions. Important factors for cell growth include the composition of the nutrient medium, mixing efficiency, temperature, dissolved oxygen saturation and pH.

Products: BIOSTAT® CultiBag STR Plus, Palletank, Sartocheck 4plus, FlexAct®, Sartoclear® L-Drum

Filtration in Biopharmaceutical Processes

In biomanufacturing of monoclonal antibodies, vaccines and therapeutic proteins, filtration is an essential step in this process chain. Therefore, single-use filters are used for reducing the bioburden and removing particles, and sterilizing-grade filters are utilized to perform sterile filtration in final filling. These disposable filters are already validated, presterilized and ready to use right “out of the box.” As a result, they eliminate the added costs of cleaning the housing and of validation of the cleaning procedure.

Products: Sartobran P MaxiCap, Sartopore 2 MaxiCaps, Sartopore 2 XLG MaxiCaps, Sartopore 2 XLI MaxiCaps

Safe Storage of Biologics

Transportation and storage of biologics are key intermediate steps in the production of biopharmaceuticals. To ensure the safety of these products across the entire process chain, these liquids are filled into sterile single-use bags and stored in specially designed tanks.

Products: Flexel® 3D Palletank® for weighing, Flexel® 3D Bag

Purification of Target Proteins

After successful cell cultivation, the desired target proteins are separated by crossflow filtration from the remaining constituents of a medium. In several filtration steps, the target protein is purified until the only active pharmaceutical ingredient in the desired concentration remains. SARTOFLOW® Advanced is used in ultra-, micro- and diafiltration to purify vaccines, monoclonal antibodies or recombinant proteins. This system is ideal for flexible use in the laboratory, in process development and in clinical studies as well as for small production batches. The linear scalability of the system from 0.1 to 2.1 m2 of membrane area and its minimal loop volume of ~ 200 ml make SARTOFLOW Advanced unique.

Product: SARTOFLOW® Advanced with integrated control unit